Uh-huh.What is not an assumption is that the FDA has accepted the submission as a complete response.
What is not an assumption is that the FDA review Committee has initially assessed the submission as complete relative to the CRL and with out another trial being actioned.
A "further study" was done. You and whytee are just ignoring it and it's significance.
Both you and whytee have argued an assumption against SOPs.
Both you and whytee have argued an assumption that "isn't fair" or reasonable.
No one is arguing that we have this in the bag. Only 2 numpties have been arguing on assumptions.
2023 The Final Countdown, page-2084
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